Clinical Trial Centers Alliance

Transcription

1 Clinical Trial Centers Alliance offering specialized expertise to fit the unique needs of each client Bobbie Theodore Alliance Director

2 Executive Summary Our Alliance of experienced research sites and services can address portfolio clinical research activities. We propose flexible options to serve your clinical development needs as follows: A menu of services under one liaison and contract Expertise across a range of therapeutic areas, phase I through postmarketing Integrated services including clinical site conduct, with or without bundled CRO services such as protocol development, trial management, data management, statistical analysis, monitoring any or all to meet your clinical program needs

3 Independent (Non-SMO) entities in California, Texas, Florida, and New Mexico comprise the Alliance Combined 1,000+ clinical trials conducted, phases I-IV Central IRB Large patient databases, affiliated medical practices and proven recruitment methods

4 Alliance Facilities CALIFORNIA Collaborative Neuroscience Network, LLC Clinical Pharmacology Unit: 2600 Redondo Avenue, Suite 500, Long Beach, CA bed CPU healthy subjects, and stable psychiatry, neurology, pain, medical and ethno-bridging trials 20+ bed licensed psychiatric hospital (JCAHO accredited) acute psychiatry trials Outpatient offices Alzheimer s, neurology, pain, and medical trials Principal Investigators: David Walling, Ph.D., (CEO) Psychologist Mark Leibowitz, M.D, (Early Phase Medical Director) Internist Armen Goenjian, M.D, (Medical Director) Psychiatrist Omid Omidvar, M.D., Neurologist Nirav Patel, M.D., Neurologist Steven Reynolds, D.O., Family Practitioner

5 Alliance Facilities CALIFORNIA CNS Continued: Outpatient psychiatry offices: Valley View Street, Suite 3, Garden Grove, CA Principal Investigator: David Walling, Ph.D S. Vermont Avenue, Suite F-100, Torrance, CA Principal Investigator: Armen Goenjian, M.D.

6 Alliance Facilities CALIFORNIA Pacific Research Partners, LLC 1611 Telegraph Avenue, Suite 1550, Oakland, CA (San Francisco Bay area) Principal Investigators: Ira Glick, M.D., Psychiatrist and Anand Mehta, MD, Double Boarded in Internal Medicine and Endocrinology Inpatient and Outpatient adult psychiatry trials Outpatient Alzheimer s, pain, and general medical trials

7 Alliance Facilities - TEXAS FutureSearch Trials, LP 5508 Parkcrest Dr., Ste. 300, Austin, TX Principal Investigators: Donald Garcia, M.D., Psychiatrist, Carmen Zegarra, M.,. Psychiatrist, And John D. Hudson, M.D., Double Boarded in Neurology and Sleep Medicine Outpatient child to adult psychiatry, Alzheimer s, MCI, sleep, pain trials Inpatient - 6 bed sleep lab for PSG and sleep trials 5445 La Sierra Drive, Suite 101, Dallas, TX Principal Investigator: Michael Downing, M.D., Psychiatrist Inpatient and Outpatient adult psychiatry trials Outpatient Alzheimer's, sleep and pain trials

8 Alliance Facilities FLORIDA Florida Clinical Research Center, LLC 8043 Cooper Creek Blvd., Suite 107, Bradenton, Florida Principal Investigators: Andrew J. Cutler, M.D., (CEO) Double Board Certified in Psychiatry and Internal Medicine, and Jose T. Zaglul, M.D., Child Psychiatrist Inpatient and Outpatient psychiatry, Alzheimer s, sleep, pain and general medical trials including targeted special phase I patient populations 2300 Maitland Center Pkwy, Ste. 230, Maitland, FL Principal Investigators: Martin S. Kane, M.D., Board Certified Psychiatry and Neurology, Richard D. Knapp, D.O. Board Certified in Psychiatry and Addictions, and Joanne L. Northcutt, Ph.D., Child Health Psychologist Inpatient and Outpatient psychiatry and addiction trials including targeted special phase I Outpatient child to adult psychiatry, Alzheimer s, sleep and pain trials

9 Alliance Facilities NEW MEXICO Albuquerque Neuroscience, Inc. 101 Hospital Loop NE, Suite 209, Albuquerque, NM Principal Investigators: Glenn Michael Dempsey, M.D., (President) Psychiatrist, and Paula J. Lane, Family Practice Outpatient child to adult psychiatry, Alzheimer's, sleep, pain and general medical trials

10 Alliance Staff Highlights Full-Time Dedicated And Highly Experienced Staff Investigators are Board Certified in Psychiatry, Neurology, Sleep Medicine, Internal Medicine, Family Practice, Endocrinology, and Licensed Clinical Psychologists Protocol consultants to sponsors and CROs, and thought leaders in psychiatry, neurology, sleep and phase I study designs Full-time certified, psychometric clinical raters doctorate and M.A.-level with up to 20+ years rating experience Multiple full-time study coordinators including CCRCs, RNs, and LVNs Dedicated recruitment and outreach specialists with established referral networks in their communities Regulatory, QA, training and IT personnel

11 Alliance Capabilities Specialized Capabilities and Experience Dedicated 50 bed Clinical Pharmacology Unit (CPU) Healthy subjects Special patient populations including Asian bridging Telemetry and holter cardiac monitoring QTc and TQTc EEG and qeeg evoked potentials Serial PK and ECG Imaging, 1.5 and 3T MRI, and fmri Lumbar puncture and CSF collection PSG (polysomnography) Infusion, injection, oral, device, implant and transdermal patch delivery systems

12 Alliance Therapeutic Areas Psychiatry Phase I-IV Addictions smoking cessation, alcohol dependence, binge eating, opioid, drug ADHD adult and child, including analog classroom Anxiety GAD, PTSD Bipolar bipolar depression, mania, mixed Cognitive dysfunction Depression MDD, refractory/treatment resistant, depression with sexual dysfunction Schizophrenia and schizoaffective disorders acute, stable, cognitive dysfunction, negative symptoms Neurology Phase I-IV Alzheimer s MCI, prodromal, mild, moderate, and severe with agitation Multiple Sclerosis relapsing remitting Parkinson s early stage to advanced Post-stroke, Traumatic brain injury, movement disorders Sleep insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea, maintenance

13 Alliance Therapeutic Areas cont d Pain Phase I-IV Chronic pain Fibromyalgia Migraine Neuropathic Osteoarthritis Post herpetic neuralgia General Medical Phase I-IV Asthma, COPD Diabetes Hypercholesterolemia Hypertension Obesity OIC Respiratory Vaccines Women s health

14 Alliance Recruitment and Retention Recruitment Full-time dedicated recruitment and outreach specialists on staff Extensive databases accumulated since 2000 across all indications Affiliated PI private and group practices (psychiatry, neurology, family practice, sleep) Established relationships with physician network for patient referrals Outreach to and relationships with residential facilities, board and cares, senior communities, Japanese communities Participation in community events and support groups providing free seminars, lunch and learns History of successful print, online, radio, and television advertising Relationships with media buyers for discounted advertising rates and preferred placement Ability to pre-qualify patients via IRB-approved pre-screen consent form Retention Inpatient facilities have private rooms, double occupancy for caregivers or loved ones as needed Site-provided patient transportation as needed Full-time dedicated staff for regular communication with patient, family and caregiver, reminder and follow-up phone calls Thorough pre-screening Treating physicians allow for ease in transition and follow up

15 Alliance Affiliated Practices Affiliated Medical Practices Collaborative Neuroscience Network, CA is aligned with Drs. Goenjian, Omidvar, Patel and Reynold s large psychiatry, neurology and family group practices respectively in the LA and Orange County regions. Pacific Research Partners, CA has exclusive relationship with the largest mental health clinics in the San Francisco Bay Area regions, as well as Dr. Mehta s Bay Area Medical multi-specialty group practice. FutureSearch Trials, Austin, TX is aligned with Dr. Hudson s sleep medicine/neurology practice and sleep lab on premises of research facility. FutureSearch Trials, Dallas, TX is aligned with Dr. Downing s psychiatry practice. Both Austin and Dallas sites have established community referral relationships with several residential facilities and mental health agencies. Florida Clinical Research Center, FL is aligned with Dr. Zaglul s large child and adult mental health agency and residential facilities. Drs. Knapp and Marraffino are aligned with The Center for Drug Free Living. Albuquerque Neuroscience, NM is aligned with local elderly facilities and community advocacy groups, group psychiatric and medical practices and a large multi-specialty regional organization.

16 Alliance Advantages Advantages and Expertise Menu of site and study management services based on sponsor need Responsiveness and ease of single point of contact for all Dedicated regulatory, and budget and contract staff for quick turnaround Central IRB Best clinical and operational practices shared across sites Thought leaders in CNS and Phase I designs Multiple publications and advisory board memberships Protocol development feedback and clinical costs provided if needed Established vendor relationships for seamless execution

17 Alliance Testimonials Phase I Healthy Japanese Bridging Study Sponsor [Dr. Mark Leibowitz CNS] Congratulations on getting this study initiated so quickly! I heard that all eight subjects were successfully dosed today. Thank you for your hard work to achieve this milestone under such stringent timelines. We appreciate it greatly. Phase I Schizophrenia Study CRO I wanted to extend an extra special thank you to your [Dr. David Walling][CNS] team. Without your help today we could not have achieved the soft lock milestone. The entire team came together to meet our deliverable. Your staff stayed late on Wednesday (before coordinator s jury duty), organized the team today and helped with last minute queries. Again, thanks for your continued hard work on the project and it s been a pleasure to work with the team. Thanks. Depression Study Sponsor Dr. [Andrew] Cutler and Patricia, [Florida Clinical Research Center] YOU are NUMBER 1. My sincere appreciation and my congratulations to you for screening the first subject in the XXX depression study. The ice is broken and the ship has now sailed. Thank You Schizophrenia Study CRO Dr. [Armen] Goenjian, [CNS], Congratulations!! Your site is the first that has reached the recruitment cap of 18 patients randomized in the XXX Suboptimal study. On behalf of the team, I would like to thank you and your site staff for the hard work and for being the first site to reach this goal!! Schizophrenia Study Sponsor Dr. Ira Glick, [Pacific Research Partners] We are planning on closing the screening of potential subjects for Study XXX at the end of December. While this study has been challenging to enroll, you and your site staff have done a tremendous job, both in terms of enrollment (16 subjects screened, 7 randomized) and data quality.

18 Alliance Testimonials cont'd ADHD Study Sponsor Dr. [Andrew] Cutler, Patti, and Florida Clinical Research Center staff have been wonderful throughout their work on our studies. The team exceeded their enrollment goal and closed the study with a remarkably low screen failure and early discontinuation rate. In addition, and the quality of their work on both studies has been exceptional their source and CRF data have been clean resulting in cost and time savings for our monitoring and data management activities. Dr. Cutler has also been incredibly helpful by collaborating with our team on patient recruitment strategies, the appropriate use of our study diagnostic tool, and sharing his thoughts about future development work with the compound. Alzheimer s Study Sponsor Good afternoon Dr. [Omid] Omidvar, [CNS], I am writing to invite you to participate in a Phase IIb Alzheimer s trial. You and your team were one of the top enrolling sites for the XXX Elderly MRD trial and we think that you and your team could be perfect for the trial. Multiple Sclerosis Study Sponsor Hi all, XXX (Senior Director of Clinical Operations with XXX) came by to meet with Dr. [Nirav] Patel, Anne Cabral, and the [CNS] team to acknowledge the outstanding job we all did on the XXX (MS) spasticity study! According to some of his internal metrics, we were performing at 300+% compared to other sites. That is amazing! Migraine Study Sponsor Dr. [John] Hudson and FutureSearch Trials of Neurology] the XXX study team appreciates your efforts to reduce screen failures for this study. Currently, you have the lowest SF rate out of 40 US sites and the most randomized patients. XXX appreciates your efforts and expertise in this clinical trial. Insomnia Sleep Sponsor Dear Dr. [John] Hudson, [FutureSearch Trials of Neurology], I hope you are doing well. I was reviewing the XXXsponsored trial enrollment numbers in my region, and was impressed with your enrollment numbers in the PSG study. I just wanted to say thank you so much for all of the hard work by you and your staff!

19 Alliance Sample Metrics Study Title # of Patients Screened # of Patients Randomized Length of Enrollment Year Status Phase I, Open-Label, Randomized, Multiple Dose, Safety and Pharmacokinetic Trial with Injectable XXX Compared to XXX in Patients with Chronic, Stable Schizophrenia or Schizoaffective Disorder Contracted for 4 cohorts of 10 (40) Screened patients Plus back up subjects 3 months 2015 Active Phase I, Rising Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XXX in Healthy Adult Japanese Subjects - Part I and II Contracted for 2 cohorts of 8 (16) Enrolled 16 < 2 months over the holidays Nov- Dec 2014 Active Phase I, Prospective, Randomized, Double-blind, Placebo-controlled, Sequential-cohort, Escalating, Single-dose Study designed to determine the maximum tolerated oral dose of XXX in Healthy, Male volunteers 3 days/2 overnights Contracted for 5 cohorts of 12 (60) Screened 110 Enrolled 60 plus back up subjects 5 months Closed Phase I, Randomized Single-Blind, Placebo-Controlled, Ascending Single Oral Dose Study Assessing the Safety, Tolerability, and Pharmacokinetics of XXX in Male and Female Subjects with Schizophrenia AND Ascending Multiple Oral Dose Study Phase I, Randomized, Double-Blind, Placebo-Controlled Study of Safety and Pharmacodynamic Effects of XXX in Major Depressive Disorder Subjects (Extensive PKs & multiple ECGs) Phase I, Randomized, Double-Blind, Placebo-Controlled, Combined Single Ascending Dose and Multiple Ascending Dose Study to Assess Safety, Tolerability, Immunogenicity, Pharmacodynamic Response, and Pharmacokinetics of Intravenous Infusions of XXX in Subjects With Mild to Moderate Alzheimer s Disease Contracted for 7 cohorts of 15 (105) Screened 128 Enrolled 93 plus back up subjects weeks (across 2 Alliance sites) Study design 5 cohorts; 1 pt/cohort from ea site 20 patients enrolled (2 cohorts of 10 each) 3 months 2014 RESCUE SITE 12 months TOP ENROLLING SITE TOP ENROLLING SITE

20 Sample Metrics cont d Study Title Phase II, 12 Week Randomized, Double-blind, Placebocontrolled, Parallel Group, Multiple Dose, Proof-of- Concept Study to Evaluate the Effects of XXX on Cognition in Stable Schizophrenia Patients Phase I, Open-label, Multiple Dose, Safety and Tolerability Study of XXX IM Depot Administered in the Deltoid Muscle in Adult Subjects with Schizophrenia Double-Blind, Placebo-Controlled, Flexible-Dose Study of XXX in Patients with Generalized Anxiety Disorder Phase IV, Multi-national, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of XXX compared to Placebo for Smoking Cessation Through Reduction Phase III, Long-Term Open-Label Study of the Safety and Tolerability of XXX in Patients with Bipolar I Disorder Phase III, Double-Blind, Randomized, Multi-Center, Placebo-Controlled, Relapse Prevention Study with XXX in Out-Patient Adults with Major Depressive Disorder # of Patients Screened # of Patients Randomized months (across 2 Alliance sites) Length of Enrollment Year Status 2013 Closed month 2013 Closed months (across 2 Alliance sites) 2013 Closed months 2011 Closed months 2011 TOP ENROLLING SITE months 2010 Closed

21 Sample Metrics cont d Study Title Open Label Study to assess the feasibility of EVO, game-play, to engage subjects with Attention Deficit Hyperactivity Disorder (ADHD) and to evaluate interference cost in children ages 6 to 12 years old with ADHD compared to age-matched controls Phase III, Randomized, Double-blind, Placebo-Controlled Study of the Safety and Effectiveness of XXX for the Treatment of Mild to Moderate Alzheimer s Disease (includes IGIV, and infusion) Open-Label, Randomized, Multi-Center, Parallel-Arm Study to Assess the Safety and Tolerability of XXX 40 mg/ml Three Times a Week Compared to 20 mg/ml Daily Subcutaneous Injections in Subjects with Relapsing-Remitting Multiple Sclerosis Phase II, Double-blind, Randomized, Placebo-controlled, Multicenter, Fixed-dose, Study to Assess Efficacy, Safety and Tolerability of XXX in Adults with Inattentive-Predominant Attention Deficit/ Hyperactivity Disorder (ADHD) Phase IIa Randomized, Double-Blind, Cross over Study Comparing the Tolerability of Two Dose Regimens of XXX in Adult Patients with Parkinson's Disease who are receiving XXX # of Patients Screened # of Patients Randomized months (across 2 Alliance sites) Length of Enrollment Year Status 2013 Closed months 2013 TOP ENROLLING SITE weeks 2013 Closed months 2012 Closed month 2010 RESCUE SITE

22 Sample Metrics cont d Study Title Phase III, Open-Label, Multicenter Study to Assess the Long - Term Safety of XXX Once-Daily in Subjects with Moderate to Severe Chronic Nonmalignant and Non-neuropathic Pain Phase I, Inpatient Open-Label, Randomized, Parallel Group, Crossover Study to Compare the Pharmacokinetcs of XXX in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period Phase III, Double-blind, Randomized, Placebo-controlled, Safety and Efficacy Study of Once Daily Controlled Release XXX in the Treatment of Patients with Fibromyalgia (13-week single and double blind phases, outpatient study including Actigraphy, PK, Multiple Psychiatric, Sleep & Pain Assessments, and Diary) Phase III, Multicenter, 12-Month, Open-Label, Single-Arm, Safety Study of XXX and XXX Extended-Release Capsules in Subjects With Moderate to Severe Chronic Non-cancer Pain # of Patients Screened # of Patients Randomized Length of Enrollment Year Status months 2012 Closed (SFs due to pts not having a migraine in req d window) 8 months 2012 TOP ENROLLING SITE months 2011 TOP ENROLLING SITE months 2011 TOP ENROLLING SITE Phase II/III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of XXX for Prevention of Menstrually Related Migraine in Female Patients with Episodic Migraine months (across 2 Alliance sites) 2010 Closed

23 Alliance PI's Curricula Vitae Click on name below to download CV David P. Walling, Ph.D. CEO and PI CNS, LLC Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner CNS, LLC Omid Omidvar, M.D. PI CNS, LLC Nirav S. Patel, M.D. PI CNS, LLC Steven Reynolds, D.O. PI CNS, LLC Mark Leibowitz, M.D. PI CNS, LLC Ira D. Glick, M.D. PI Pacific Research Partners, LLC Anand Mehta, M.D. PI Pacific Research Partners, LLC John Douglas Hudson, M.D. PI FutureSearch Trials of Neurology, LP Michael Downing, M.D. PI FutureSearch Trials of Dallas, LP Andrew J. Cutler, M.D. CEO and PI Florida Clinical Research Center, LLC Jose T. Zaglul, M.D. PI Florida Clinical Research Center, LLC Richard D. Knapp, D.O. PI Florida Clinical Research Center, LLC Joanne Northcutt, Ph.D. PI Florida Clinical Research Center, LLC Martin Kane, M.D. PI Florida Clinical Research Center, LLC Glenn Michael Dempsey, M.D. PI Albuquerque Neuroscience, Inc Paula J. Lane, M.D. PI Albuquerque Neuroscience, Inc

24 Contact For further information on Alliance services contact: Bobbie Theodore (916)